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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000032965
Receipt No. R000037581
Scientific Title Effects of medical equipments that improve physical functions on psychological states
Date of disclosure of the study information 2018/06/18
Last modified on 2019/05/08

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Basic information
Public title Effects of medical equipments that improve physical functions on psychological states
Acronym Effects of medical equipments that improve physical functions on psychological states
Scientific Title Effects of medical equipments that improve physical functions on psychological states
Scientific Title:Acronym Effects of medical equipments that improve physical functions on psychological states
Region
Japan

Condition
Condition Depressive symptoms
Classification by specialty
Medicine in general Psychosomatic Internal Medicine Psychiatry
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In recent years, it is becoming apparent that various organs and cells exchanges information dynamically through several neurotransmitters in the body and this phenomenon supports physical and mental health conditions. In this study, we attempt to reveal the effects of medical equipments that improve physical functions on psychological states such as flow experiences, empathy, and stress coping abilities.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes After 10-minute physical stimulation using a low frequency therapy device or a dry hot pack device, we ask the participants to conduct psychological tasks that can evaluate flow experiences / empathy / stress coping abilities and quantitatively evaluate the influence of transient physical stimulations on flow experiences / empathy / stress coping abilities .
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Perform a 10-minute physical stimulation using a low frequency electric therapy equipment or dry hot pack equipment(program 1).
Interventions/Control_2 Perform a 10-minute physical stimulation using a low frequency electric therapy equipment or dry hot pack equipment (program 2).
Interventions/Control_3 Perform a 10-minute sham-physical stimulation using a low frequency electric therapy equipment or dry hot pack equipment.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria Healty people
Key exclusion criteria Those who fall under the following which are thought to have a large electric influence compared with the intended effect are excluded. 1.people using psychotropic drugs and drugs that affect the mental state 2. people with sensory disorders such as dull warmth 3. pregnant women 4. people with malignant tumors and heart disease 5. people with skin irritation, injury or lesions 6. people who have a febrile disease, acute inflammation, and purulent disease 7. people who have a possibility of blood flow disorder 8. people who suffer from deep thrombophlebitis 9. people who judged that the doctor is inappropriate
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Matsunaga
Organization Aichi Medical University School of Medicine
Division name Department of Health and Psychosocial Medicine
Zip code 4801195
Address 1-1 Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Email matsunag@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Matsunaga
Organization Aichi Medical University School of Medicine
Division name Department of Health and Psychosocial Medicine
Zip code 4801195
Address 1-1 Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Homepage URL
Email matsunag@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University School of Medicine
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research <KAKENHI>
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Aichi Medical University
Address 1-1 Yazakokarimata, Nagakute, Aichi
Tel 0561623311
Email sec2030@mail.aichi-med-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Suspended
Date of protocol fixation
2018 Year 05 Month 25 Day
Date of IRB
2018 Year 05 Month 07 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 13 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037581

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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